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Product Summary

PRESCRIPTION REQUIRED

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

NORELGESTROMIN/ETHINYL ESTRADIOL PATCH - TRANSDERMAL

(ETH-in-il ess-tra-DYE-ole/nor-el-JESS-troh-min)

COMMON BRAND NAME(S): Ortho Evra

WARNING: Smoking cigarettes/using tobacco while using this medication increases your chance of heart problems or stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).

USES: This medication is a combination of 2 hormones (an estrogen and a progestin) and is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also can work by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and by changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. Using this medication does not protect you or your partner against HIV or other sexually transmitted diseases (STDs). Studies have shown that the total amount of estrogen you receive when using the patch is higher than the amount from most birth control pills. This may increase the risk for blood clots or other side effects from the birth control patch compared to the pill. If you weigh more than 198 pounds (90 kilograms), this patch may not work as well for you. Make sure your doctor knows your current weight, and ask about which form of birth control is best for you.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Make sure you understand how to apply a new patch and dispose of the used product. If you have any questions, consult your doctor or pharmacist. Remove the patch from the foil pouch and apply as directed by the manufacturer. Apply one patch to an area of clean, dry skin on the buttock, abdomen, upper outer arm, or upper body (torso) where it will not be rubbed by tight clothing. Change the patch once a week, and wear a patch continuously for 3 weeks or as directed by your doctor. The chance of becoming pregnant increases with incorrect use, so follow the directions carefully and make sure the patch stays in place. Do not apply the patch on or near a breast, to red/cut/irritated skin, or over other skin products (e.g., make-up, lotions, powders). Apply the patch to a different area on your body each time to avoid irritation. If this is the first time you are using this medication, apply the patch on the first Sunday following the beginning of your menstrual period or on the first day of your period. If your period begins on a Sunday, begin on that day. For the first cycle of use only, use an additional form of non-hormonal birth control (e.g., condom or spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you start the first patch on the first day of your period, you do not need to use back-up birth control the first week. Change the patch once weekly on the same day. Remember to remove the old patch before placing a new patch. After wearing patches continuously for 3 weeks, do not apply a patch during week 4. You should have your period during this time. If you do not get your period, consult your doctor. After not wearing a patch for a week, apply a new patch whether or not you have your period. Do not go longer than 7 days without a patch, or you will increase your risk of becoming pregnant. It may be helpful to mark a calendar to remind you when to change the patch and which week to leave it off. If the patch comes off at the wrong time, replace with a new patch within 24 hours. If the patch is not replaced quickly, or if you are not sure how long it has been off, you could become pregnant. Start a new cycle by applying a new patch on the day you remember, and use an additional form of non-hormonal birth control (e.g., condom or spermicide) for 7 days to prevent pregnancy. Continue to apply patches for a total of 3 weeks. After removing each patch, fold it in half so it sticks to itself, and discard in the trash away from children and pets. Do not flush the patch down the toilet. Ask your doctor or pharmacist for information about switching from other forms of birth control to the patch. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

SIDE EFFECTS: Vaginal bleeding between periods (spotting) may commonly occur during the first few months of use. If this bleeding is persistent or unusually heavy, contact your doctor. Nausea, vomiting, headache, redness/irritation at the application site, dizziness, breast tenderness/enlargement, vaginal discomfort/irritation, increased vaginal discharge, missed/irregular periods, acne, or stomach cramping/bloating may occur. If you miss 2 periods in a row (or 1 period if the patch has not been used properly), talk to your doctor about a pregnancy test. If any of these effects persist or worsen, notify your doctor. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), unwanted facial/body hair (hirsutism), dark patches on the skin (melasma), mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), swelling of the ankles/feet, weight changes (gain or loss), problem wearing contact lenses. This medication may rarely cause serious (sometimes fatal) blood clot problems (e.g., thrombosis, pulmonary embolism, stroke, heart attack). The risk for blood clots may be higher for the birth control patch than for the pill. Seek immediate medical attention if you experience: tingling/weakness/numbness in the arms/legs, pain/swelling/warmth in the groin/calf, chest/jaw/left arm pain, confusion, coughing up blood, sudden shortness of breath, sudden dizziness/fainting, weakness on one side of the body, vision problems/changes, slurred speech, sudden severe headaches, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, yellowing eyes/skin, unusual tiredness, dark urine. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section. Before using this medication patch, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, breathing problems (e.g., asthma), cancer (especially endometrial or breast cancer), blood clotting disorders (such as protein C or protein S deficiency), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, kidney problems, liver problems (e.g., liver tumor), current or suspected pregnancy, seizure, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over). Before using this medication, tell your doctor or pharmacist your medical history, especially of: high cholesterol or triglyceride (blood fat) levels, depression, diabetes, high blood pressure, fluid retention (edema), gallbladder problems, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems. Do not smoke cigarettes. Hormonal birth control (e.g., pills, injections, devices) products combined with smoking cigarettes significantly increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist or consult the Patient Information Leaflet that comes with this product. Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions in these circumstances while you are using this drug. The drugs in this patch may cause blotchy, dark areas on your skin (melasma). Sunlight may intensify this effect. If this occurs, avoid prolonged sun exposure, use a sunscreen, and wear protective clothing when outdoors. If you are nearsighted or wear contact lenses, you may develop vision problems or may have problems wearing your contact lenses. Contact your eye doctor if these problems occur. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication. The medication from this patch passes into breast milk and may have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: acetaminophen, aromatase inhibitors (e.g., anastrazole, exemestane), ascorbic acid (vitamin C), atorvastatin, azole antifungals (e.g., itraconazole, ketoconazole), certain benzodiazepines (e.g., diazepam, lorazepam, temazepam), clofibric acid, corticosteroids (e.g., prednisolone), cyclosporine, metoprolol, morphine, phenylbutazone, raloxifene, sodium tetradecyl sulfate, tamoxifen, theophylline, medication for low thyroid (hypothyroidism). Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others. Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. This medication can affect the results of certain lab tests (e.g., blood tests such as glucose, clotting factors, lipids, thyroid). Make sure laboratory personnel and all your doctors know you use this medication. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: Overdose with this medication is highly unlikely. However, if overdose is suspected, remove the patch and contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication patch with others. Keep all laboratory and medical appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.

MISSED DOSE: If the patch comes off or you forget to remove it at the proper time, consult the Patient Information Leaflet or your doctor or pharmacist to establish a new dosing schedule. You may need to use a back-up form of birth control (e.g., condoms or spermicide) to prevent pregnancy. If you have trouble remembering to change your patch, or if the patch falls off repeatedly, contact your doctor to discuss switching to another form of birth control.

STORAGE: Store in protective foil pouches at room temperature at 77 degrees F (25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not refrigerate or freeze. Protect from light and moisture. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed (See How to Use section).

Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.

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